Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Information source: Seattle Children's Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemangioma
Intervention: Prednisolone (Corticosteroid) (Drug); Propanolol (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Seattle Children's Hospital Official(s) and/or principal investigator(s):
Jonathan A Perkins, DO, Principal Investigator, Affiliation: Seattle Children's Hospital
Overall contact:
Jonathan A Perkins, DO, Phone: 206-987-3468, Email: hemangioma.research@seattlechildrens.org
Summary
This is a prospective randomized, double-blind study to compare the clinical efficacy of
infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy
with corticosteroids and placebo. We hypothesize that a two-month treatment period with
propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and
vascularity when compared to corticosteroids used without propranolol for the same time
period.
Clinical Details
Official title: A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Compare changes in IH size and vascularity for subjects randomized to receive initial treatment with corticosteroid-only therapy versus combination therapy with corticosteroids plus propranolol
Secondary outcome: Determine therapeutic response of IH to propranolol among patients who switch to corticosteroids plus propranolol therapy after failing to respond to corticosteroids alone.Assess the safety of propranolol with corticosteroids and corticosteroids alone in the treatment of IH. Demonstrate how duplex scanning to assess blood vessel density and qualitative color ratings of cutaneous lesions from photographs can be used to measure and quantify changes in IH size and vascularity in a clinically relevant manner.
Detailed description:
Infantile hemangiomas (IH) are the most common head and neck pediatric tumors. Presence of
these tumors can lead to complications of vision and airway compromise, bleeding and
disfigurement. Medical treatment of these lesions has traditionally been focused on stopping
new blood vessel growth with corticosteroids. Recent reports and our own experience have
demonstrated that significant reduction in IH size and vascularity can also occur through
the use of propranolol. Our initial experience with propranolol has demonstrated
significant efficacy with fewer side effects than corticosteroids. Despite this experience,
the standard of care for initial IH medical therapy remains corticosteroids.
This Trial is a direct comparison of traditional IH therapy with corticosteroids to newer
therapy with propranolol and corticosteroids.
Eligibility
Minimum age: N/A.
Maximum age: 9 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 0 to < 9months
- Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma
(IH) requiring medical treatment
- IH patients whose parents desire medical treatment for the IH
- Stable cardiac function
Exclusion Criteria:
- IH patients over 9 months of age.
- Hypersensitivity to propranolol
- Untreated heart failure: If the patient has heart failure associated with the
hemangioma, propranolol would be initiated after anti-congestive therapy and under
observation as an in-patient.
- AV block
- Resting heart < 2SD of normal*(below)
- Resting blood pressure < 2SD of normal**(below)
- WPW (Wolff-Parkinson-White syndrome)
- History of unexplained syncope
- Bronchial asthma
- History of impaired renal or liver function
- Diabetes mellitus
Locations and Contacts
Jonathan A Perkins, DO, Phone: 206-987-3468, Email: hemangioma.research@seattlechildrens.org
Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Jonathan A Perkins, DO, Email: hemangioma.research@seattlechildrens.org
Stacy M Russ, Email: stacy.russ@seattlechildrens.org
Robert Boucek, MD, Sub-Investigator
Jonathan A Perkins, DO, Principal Investigator
Robert Sidbury, MD, Sub-Investigator
Scott C Manning, MD, Sub-Investigator
Fredric A Hoffer, MD, Sub-Investigator
Eden Palmer, Sub-Investigator
Heather Brandling-Bennett, MD, Sub-Investigator
Michelle Sadler-Greever, RN, BSN, CDE, Sub-Investigator
Linnea Brody, MPH, Sub-Investigator
Jack N. Vo, MD, Sub-Investigator
Sandeep S. Vaidya, MBBS, Sub-Investigator
Additional Information
Seattle Children's Vascular Anomalies Program Research Flyer
Starting date: February 2010
Last updated: August 18, 2010
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